Senior Associate Manufacturing, Upstream - Days (Multiple Positions)

Role Summary

Senior Associate, Upstream (Days) supports Amgen's 24/7 upstream manufacturing operations at Amgen North Carolina. This on-the-floor role executes cGMP drug substance manufacturing in the upstream area on a 12-hour 2-2-3 schedule (5:45 am–6:15 pm). The position requires hands-on operation, on-the-floor execution of process steps, documentation, and cross-functional collaboration to ensure safe, compliant production of drug substances.

Responsibilities

• Compliance: Complete work in accordance with established cGMP procedures and policies (SOPs, MPs, JHAs, CFR) with strict adherence to safety and compliance.
• Initiate quality observations (discrepancies, deviations, testing results analysis) and support or lead evaluations and investigations into quality observations.
• Interact with regulatory agencies as needed and guided.
• Ensure proper gowning and aseptic techniques are always followed.
• Process/Equipment/Facilities: Perform hands-on operations including setup, cleaning, sanitization, and monitoring of equipment in the assigned area.
• Run and monitor critical process tasks per assigned procedures.
• Perform in-process sampling, operate analytical equipment, and complete process documentation (Electronic Batch Records).
• Complete washroom activities: cleaning equipment of various scales used in production activities.
• Identify, recommend, and implement innovative process improvements and optimizations related to daily routine functions.
• Assist in the review of documentation for assigned functions (equipment logs, EBRs, ESPs).
• Collaborate cross-functionally (QA/QC, F&E, PPIC, Mfg., PD, Regulatory, etc.) in completing production activities.
• Recognize and elevate problems during daily operations.
• Participate in the implementation of programs and CAPAs with an eye toward continuous improvement.
• Drive safety in all operations, and assist the manager in escalating concerns as needed.
• Maintain an organized, clean, and workable space.
• Administrative: Draft and revise documents (SOPs, technical reports, and MPs) and interact with management as an advisor in planning and escalating potential concerns with the schedule/process.

Qualifications

• Required: High School Diploma/GED + 4 years manufacturing and/or other regulated environment experience OR Associate’s Degree + 2 years manufacturing and/or other regulated environment experience OR Bachelor’s Degree + 6 months manufacturing and/or other regulated environment experience OR Master’s Degree
• Preferred: Completion of NC BioWork Certificate Program
• Preferred: Experience in biotechnology or pharmaceutical plant start up
• Preferred: Knowledge and process experience within a cGMP manufacturing facility or other highly regulated environment
• Preferred: Basic understanding of Upstream operation (Vial Thaw, Inoculation/Cell Expansion, Single Use Bioreactor, Production Bioreactor, ATF, Harvest Centrifuge, Depth Filtration)
• Preferred: Excellent verbal and written communication (technical) skills
• Preferred: Proficient Microsoft Office skills, and knowledge of other electronic systems such as EBR/MES, Delta V, and Electronic Quality Systems

Education

• High School Diploma/GED with 4 years manufacturing and/or other regulated environment experience
• Associate’s Degree with 2 years manufacturing and/or other regulated environment experience
• Bachelor’s Degree with 6 months manufacturing and/or other regulated environment experience
• Master's Degree

Additional Requirements

• Must be able to work a 12-hour shift on a 2-2-3 schedule (5:45 am–6:15 pm) and be available for overtime, inclement weather, and some holidays to support 24/7 operations.